About this role
Maintain self-hygiene and ensure compliance with cGMP, GDP and departmental discipline.
Prepare and review the master documents, protocols and reports of production as per requirements.
Manage the Exhibit batch documents such as BMRs, BPRs, etc.
Handle change control, deviations, CAPA, investigation, etc.
Train all the subordinates, technicians and operators of the department.
Perform other activities as per HOD’s requirement and guidance.
Attend and ensure training as per training schedule and TNI.
Review BMR, BPR and other Exhibit batch related documents.
Skills:
Change control, deviations, CAPA, investigation, BMR, BPR, SOP.
Other facts
About Amneal
Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) is guided by a simple belief: essential medicines should be accessible to everyone. What began as a promise to deliver high-quality, affordable medicines has evolved into a diversified portfolio spanning complex generics and injectables, biosimilars, and specialty medicines, including more than 290 products, with scale and capabilities that help reach patients across the healthcare system while combining world-class precision with a deep sense of personal responsibility for every dose we deliver.
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Amneal recommends that you consult with your healthcare provider regarding personal health matters. To report a product complaint or adverse event related to an Amneal product, contact Drug Safety at 877-835-5472, option 3 or [email protected]. If you are currently experiencing a life-threatening event, please immediately contact 911.
What you'll do
- The Senior Executive will maintain compliance with cGMP and GDP while managing production documentation and handling change controls. They will also train subordinates and perform additional activities as required by the Head of Department.
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